Your browser does not support JavaScript! XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (TRICLOSAN) SOAP [REJOICE INTERNATIONAL, INC.]
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XTRACARE ANTIBACTERIAL HAND CLEANSE ORIGINAL (triclosan) soap
[Rejoice International, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active Ingredient                                 Purpose

Triclosan 0.15%................................Antibacterial

Antibacterial moisturizing Hand Soap

Original

Kills the Germs

Elimiates bacteria on hands

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

for hand washing to decrease bacteria on the skin.

Warnings

for external use only

When using this product avoid contact with eyes.  In case of eye contact, flush with water.

Stop use and ask a doctor if irritation and redness develops.

Directions

  • pump into hands
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly.

Inactive Ingredients

water, sodium c14-16 olefin sulfonate, sodium laureth sulfate, cocamide DEA, sodium chloride, PEG-150 distearate, fragrance, citric acid, glycerin, disodium EDTA, aloe barbadensis leaf juice, methylchloroisothiazolinone, methylisothiazolinone, fd&c yellow no. 5, d&c red no. 33.

Other information

  • store at room temperature
DISTRIBUTED BY:REJOICE INTERNATIONAL, INC.48325 BINGHAMPTON DR., NORTHVILLE, MI 48168, USAMADE IN CHINA

label image

XTRACARE ANTIBACTERIAL HAND CLEANSE  ORIGINAL
triclosan soap
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57337-022
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN6.6   in 443 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM C14-16 OLEFIN SULFONATE 
SODIUM LAURETH SULFATE 
COCO DIETHANOLAMIDE 
SODIUM CHLORIDE 
PEG-150 DISTEARATE 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
EDETATE DISODIUM 
ALOE VERA LEAF 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
FD&C YELLOW NO. 5 
D&C RED NO. 33 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57337-022-01443 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/03/2013
Labeler - Rejoice International, Inc. (078741245)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(57337-022)

Revised: 9/2013
 
Rejoice International, Inc.

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